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Quality Assurance Specialist

2 months ago

California, Missouri, United States Allergan Full time
Company Overview

Allergan is dedicated to pioneering and delivering groundbreaking therapies that address significant health challenges today and prepare for the medical needs of tomorrow.

Our commitment is to make a profound difference in the lives of individuals across various critical therapeutic domains, including immunology, oncology, neuroscience, and eye care, alongside our offerings in the Allergan Aesthetics portfolio.

For further insights about Allergan, please visit our website and follow us on our social media platforms.

Position Overview

The Quality Assurance Specialist will play a vital role in the development of medical devices and the components of combination products. This includes providing expertise in design control, usability engineering, and risk management processes.

Key Responsibilities:

  • Assist in the implementation of quality assurance measures, process controls, and Corrective Actions/Preventative Action (CAPA) systems to ensure compliance with internal and external standards.
  • Lead risk assessment initiatives, including the formulation of quality plans for risk analysis, development of risk controls, and verification of their effectiveness.
  • Develop and maintain control plans, Standard Operating Procedures (SOPs), testing methodologies, quality alerts, and non-conformance trend analyses.
  • Represent the Quality Assurance function in product and process development teams.
  • Conduct Design of Experiments (DOE) and Process Characterization to optimize processes using statistical analysis techniques.
  • Engage actively in design reviews and support design activities, including verification, validation, and usability engineering.
  • Collaborate with design engineering to complete product verification and validation processes.
  • Evaluate testing protocols and reports to ensure they meet regulatory and quality standards.
  • Ensure adherence to regulatory requirements and company policies, particularly FDA 21 CFR 820, ISO 13485, and ISO 14971.
Qualifications

The ideal candidate will possess a Bachelor's degree or equivalent in Mathematics, Industrial Engineering, Biomedical Engineering, or a closely related field, along with at least one year of relevant experience in:

  • Statistical analysis techniques, including Gage Repeatability & Reproducibility, Tolerance intervals, and Process Capability assessments.
  • Installation Qualification, Operational Qualification, Performance Qualification, and Process Performance Qualification.
  • Implementing quality assurance measures and process controls.
Compensation

The salary range for this position is competitive and commensurate with experience.

Additional Information

Allergan offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and a 401(k) plan for eligible employees. This role is also eligible for participation in our incentive programs.

Allergan is committed to fostering an inclusive workplace that values diversity and integrity. We strive to employ qualified individuals without discrimination based on race, color, religion, national origin, age, sex, disability, or any other legally protected status.